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IRCT20160703028756N5 IRCT 2018-12-23 Esfahan University of Medical Sciences Evaluation of efficiency and side effects of intrauterine insemination (IUI) catheter in infertile couples Evaluation of efficiency and side effects of intrauterine insemination (IUI) catheter, a product of Slamtyar Hakim Engineering company, in infertile couples 2019-01-05 anticipated 60 Complete https://irct.ir/trial/35026 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a continuous sampling method based on the criteria for entering and leaving the study is used. The method of assigning samples to the groups is a randomized block design with two blocks of four blocks. The letter A for the masstec catheter and the letter B for the PM IU catheter group are considered. Then write all the permutation combinations of the letters A, A, B, and B, which are six different combinations (AABB for digit 1, ABBA for digit 2 ...), then we select a digit from the digits 1 to 6. For example, if digit 2 is selected, its concept is that the first person in the intervention group is the next two in the control group and the fourth in the intervention group. Continue this until the sample size reaches to the quorum. . N/A Infertility. Intervention 1: In the control group, intrauterine insemination of the sperm will be performed by a catheter from France. Intervention 2: Intervention group: In the intervention group, IUI is performed by the IUI catheter ® masstec (Salamat Yar Hakim, Iran). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Fatemeh Maghool
No. 12, Yas Block 8, Keshvari Complex, Third Abshar Ave.
Isfahan Iran (Islamic Republic of) 8169333463 +98 31 9501 6799 fmaghool@gmail.com Poursina Hakim Digestive Diseases Research Center scientific Fatemeh Maghool
No. 12, Yas Block 8, Keshvari Complex, Third Abshar Ave.
Isfahan Iran (Islamic Republic of) 8169333463 +98 31 9501 6799 fmaghool@gmail.com Poursina Hakim Digestive Diseases Research center Iran (Islamic Republic of) Iran (Islamic Republic of) Having 2 to 3 follicles of the right size, Tubes open Acceptable Sperm Test for IUI no limit 42 years Female Women older than 42 years Double-sided tubular obstruction Couples with sperm concentration less than 10 million spermatozoa per ml N97 Female infertility Treatment - Devices Treatment - Devices In the control group, intrauterine insemination of the sperm will be performed by a catheter from France. Intervention group: In the intervention group, IUI is performed by the IUI catheter ® masstec (Salamat Yar Hakim, Iran). Problem with catheter insertion. Timepoint: At the time of IUI. Method of measurement: Questionnaire. Need to Tenaculum. Timepoint: At the time of IUI. Method of measurement: Questionnaire. Need for cervical dilatation. Timepoint: At the time of IUI. Method of measurement: Questionnaire. Chemical pregnancy rate. Timepoint: 2 weeks after IUI. Method of measurement: HCG Test. Clinical pregnancy rate. Timepoint: 5 weeks after IUI. Method of measurement: Sonography. Salamat Yar Hakim Engineering Co Salamat Yar Hakim Engineering Co Salamat Yar Hakim Engineering Co Approved 2018-10-29 Ethics Committee of Isfahan University of Medical Sciences خیابان هزار جریب اصفهان Isfehan Iran (Islamic Republic of)